- Responsible for review and approval of Change control, OOS, Deviation CAPA and Customer complaints.
- Review and approval of technical documents.
- Responsible for COA release.
- Responsible for conducting training as required.
- Responsible for conducting spot checks and internal audits.
- Responsible for facing customer and regulatory audits if required.
- Overdue QMS shall be Nil
- No Critical observation during audits
- No repetitive audit findings during customer or regulatory audits.
Technical / Behavioural / Managerial / Critical Skills Desired:
- Familiar with current Regulatory GMP requirements.
- Familiar with 21 CFR part 11 compliance
- Familiar with Computer system validation and equipment qualification.
- Excellent written and verbal communication skills
Additional Comments / Any other specific requirements:
- Local FDA approval
- Experience in Continual Improvement
Salary: Not Disclosed by Recruiter
Role:Quality Assurance/Quality Control Executive
Desired Candidate Profile
UG:B.Sc - Chemistry, B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy, MS/M.Sc(Science) - Chemistry
SGS India Pvt. Ltd.